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This device is designed for use by hemodialysis professionals to verify the conductivity, temperature, and pH of solutions in the hemodialysis setting.

This device is a hand-held battery powered, multi-test meter designed for use by hemodialysis professionals to measure the conductivity, temperature and pH of Dialysate solutions associated with the dialysis treatment. The unit houses the conductivity cell, electronic circuitry and digital display. A syringe attaches to the unit with luer connectors. When pulled, the syringe creates a vacuum and draws solution through the conductivity cell for measurement. The conductivity cell contains the conductivity electrodes, a thermistor, and a pH electrode. A 3.6 volt battery provides power.

The provided text is a 510(k) Summary for the Phoenix XL Dialysate Meter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the comprehensive study results of the new device. However, it does provide some information that can be used to infer acceptance criteria and aspects of the study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The table below reconstructs the acceptance criteria based on the "Technological Characteristics" comparison with the predicate device. The "Reported Device Performance" is implied to meet these criteria, as the document states the device is "substantially equivalent" and that "the results of the validations show that the pHoenix XL Dialysate Meter is equivalent to the pHoenix Dialysate Meter for measuring Conductivity, pH, and temperature."

Note on Conductivity Accuracy: The new device (Phoenix XL Dialysate Meter) actually improves on the predicate's conductivity accuracy in the range of 120.0 to 200.0 mS/cm (±5.0 mS/cm for the new device vs. ±30.0 mS/cm for the predicate). This demonstrates it meets or exceeds the predicate's performance.

2. Sample size used for the test set and the data provenance

The document states: "Nonclinical Validation of the performance of the device was performed on units equivalent to production."

• Sample size: Not explicitly stated. The phrase "units equivalent to production" suggests more than one unit, but a specific number is not provided.
• Data provenance: Not explicitly stated. However, nonclinical validation of a device manufactured by Mesa Laboratories, Inc., located in Colorado, USA, implies the testing would have been conducted internally or by a contracted lab within the USA. The study design is a nonclinical validation, meaning it does not involve human subjects. It would be considered prospective as it's testing a new device designed for market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device measures physical parameters (conductivity, temperature, pH) directly, rather than interpreting images or clinical data where expert consensus would be required for ground truth. The "ground truth" would be established by reference standards or highly accurate laboratory equipment.

4. Adjudication method for the test set

Not applicable. As noted above, the measurements are direct physical parameters, not subjective assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic or interpretation tool. It is a measurement device where human readers are not involved in interpreting its "output" in a comparative effectiveness study sense.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation was conducted. The "Nonclinical Validation" specifically assesses the device's ability to measure conductivity, pH, and temperature. The device itself (the "algorithm" in this context) directly provides the measurements without human interpretation or intervention in the measurement process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this type of device would typically be established by:

• Reference standards: Calibrated solutions with known conductivity, temperature, and pH values.
• Highly accurate laboratory equipment: Measurements taken simultaneously or sequentially by laboratory-grade instruments calibrated to primary standards.
• This is an objective physical measurement and does not rely on subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is a physical measurement device, not an AI or machine learning model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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